Methods and apparatus for injection coating a medical device

Abstract

Methods and apparatus for coating at least a portion of the surface of medical devices using an injection coating device are disclosed. In one embodiment, the invention includes a coating method wherein an orifice of the injection coating device is placed adjacent a vertically positioned medical device, coating material is ejected from the orifice onto the medical device, and the coating material gravitationally flows downward coating the medical device. In another embodiment, an orifice of an injection coating device is positioned adjacent a horizontally positioned medical device to gravitationally flow and deposit coating material onto the medical device. These methods may be used to apply one or more coating materials, simultaneously or in sequence. In another embodiment, multiple injection coating devices may be utilized. In certain embodiments of the invention, the coating materials include therapeutic or biologically active agents.

1 . A method for coating at least a portion of a medical device with a coating material comprising: 
 providing a medical device having at least one accessible surface, a proximal end, and a distal end;    holding the medical device with a holder wherein the medical device is generally vertically positioned with the proximal end above the distal end;    providing at least one injection coating device comprising an outlet orifice and a reservoir, wherein the reservoir contains a coating material and is in fluid communication with the outlet orifice;    positioning the injection coating device adjacent the proximal end of the medical device;    ejecting the coating material through the outlet orifice of the injection coating device onto the proximal end of the medical device; and    allowing the coating material to flow down at least one accessible surface of the medical device from the proximal end to the distal end, thereby depositing the coating material on at least one accessible surface of the medical device.    
     
     
         2 . The method of  claim 1  further comprising translating the medical device from a first position to a second position.  
     
     
         3 . The method of  claim 1  further comprising rotating the medical device.  
     
     
         4 . The method of  claim 1  further comprising translating the injection coating device from a first position to a second position.  
     
     
         5 . The method of  claim 1  further comprising rotating the injection coating device.  
     
     
         6 . The method of  claim 1  further comprising vibrating the holder.  
     
     
         7 . The method of  claim 1  further comprising vibrating the injection coating device.  
     
     
         8 . The method of  claim 1  further comprising drying the deposited coating material.  
     
     
         9 . The method of  claim 1  wherein the holder is a mandrel.  
     
     
         10 . The method of  claim 9  wherein the mandrel is porous.  
     
     
         11 . The method of  claim 9  wherein the mandrel comprises a vacuum core.  
     
     
         12 . The method of  claim 1  wherein the medical device is a stent.  
     
     
         13 . The method of  claim 1  wherein the injection coating device is a syringe.  
     
     
         14 . The method of  claim 1  further comprising masking at least a portion of the medical device.  
     
     
         15 . The method of  claim 1  further comprising inserting the holder into the outlet orifice of the injection coating device, wherein the ejected coating material is evenly deposited onto the proximal end of the medical device.  
     
     
         16 . The method of  claim 1  wherein the outlet orifice comprises a plurality of delivery ports circumferentially positioned along the outlet orifice.  
     
     
         17 . The method of  claim 1  wherein the outlet orifice comprises at least one delivery port wherein the delivery port is rotated circumferentially along the outlet orifice.  
     
     
         18 . The method of  claim 1  further comprising placing the medical device against the injection coating device.  
     
     
         19 . The method of  claim 1  further comprising: 
 ejecting at least a second coating material through the outlet orifice of the injection coating device onto the proximal end of the medical device; and    allowing the second coating material to flow down at least one accessible surface of the medical device from the proximal end to the distal end, thereby depositing the coating material on at least the first coating material forming a multi-layer coating material on the accessible surface of the medical device.    
     
     
         20 . The method of  claim 1  further comprising a plurality of injection coating devices.  
     
     
         21 . A method for coating at least a portion of a medical device with a coating material comprising: 
 providing a medical device having a longitudinal axis and at least one accessible surface;    holding the medical device with a holder wherein the medical device is horizontally positioned with the longitudinal axis generally horizontally aligned;    providing an injection coating device comprising an outlet orifice and a reservoir, wherein the reservoir contains a coating material and is in fluid communication with the outlet orifice;    positioning the injection coating device above the medical device;    ejecting the coating material through the outlet orifice of the injection coating device onto the medical device; and    allowing the coating material to flow down at least one accessible surface of the medical device, thereby depositing the coating material on at least one accessible surface of the medical device.    
     
     
         22 . The method of  claim 21  further comprising translating the injection coating device from a first position to a second position.  
     
     
         23 . The method of  claim 21  further comprising rotating the medical device.  
     
     
         24 . The method of  claim 22  further comprising rotating the medical device.  
     
     
         25 . A method for coating at least a portion of a stent with a coating material comprising: 
 providing a stent having at least one accessible surface, a proximal end, a distal end, and a plurality of series of interconnected struts;    holding the stent with a holder wherein the stent is generally vertically positioned with the proximal end above the distal end;    providing a plurality of injection coating devices wherein each injection coating device comprises an outlet orifice and a reservoir, wherein the reservoir contains a coating material and is in fluid communication with the outlet orifice;    positioning each injection coating device adjacent a series of interconnected struts of the stent;    ejecting the coating material through the outlet orifice of each injection coating device onto the series of interconnected struts of the stent; and    allowing the coating material to flow down at least one accessible surface of the stent from the proximal end to the distal end, thereby depositing the coating material on at least one accessible surface of the stent.    
     
     
         26 . A method for coating at least a portion of a stent with a coating material comprising: 
 providing a stent having a longitudinal axis, at least one accessible surface, and a plurality of series of interconnected struts;    holding the stent with a holder wherein the stent is horizontally positioned with the longitudinal axis generally horizontally aligned;    providing a plurality of injection coating devices wherein each injection coating device comprises an outlet orifice and a reservoir, wherein the reservoir contains a coating material and is in fluid communication with the outlet orifice;    positioning each injection coating device above a series of interconnected struts of the stent;    ejecting the coating material through the outlet orifice of each injection coating device onto the series of interconnected struts of the stent; and    allowing the coating material to flow down at least one accessible surface of the stent, thereby depositing the coating material on at least one accessible surface of the stent.    
     
     
         27 . A system for coating at least a portion of a medical device with a coating material comprising: 
 a holder adapted to secure a medical device; and    at least one injection coating device comprising an outlet orifice and a reservoir, wherein the reservoir contains a coating material and is in fluid communication with the outlet orifice;    wherein the holder is positioned adjacent the injection coating device to allow the medical device to receive the coating material ejected from the outlet orifice of the injection coating device.